MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83779
Medical Device Problem Codes	Failure to Advance (2524); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed.The introducer sheath, the main coil and the pusher wire were returned.The introducer sheath was inspected, and no damages were noted.The twist lock was opened.The main coil and the pusher wire were not interlocked inside the introducer sheath.The main coil was kinked and stretched.The pusher wire was kinked and stretched.Media inspection was performed.Pictures were provided of the device.As per pictures, it can be observed that the main coil and the pusher wire were interlocked inside the introducer sheath; nevertheless the results of the media inspection are inclusive.Microscopic inspection was performed on pusher wire.The zap tip had a smooth surface.The interlocking arm was inspected, and no anomalies was noted.Microscopic inspection was performed on the main coil and noted that the zap tip had a smooth surface.The interlocking arm was detached.Dimensional inspection of the main coil and pusher wire that could be measured were performed and were within specification.
Event or Problem Description
Reportable based on device analysis completed on 18apr2022.It was reported that the coil could not be delivered and the delivery shaft got twisted.The target lesion was located in the coronary vein of the stomach.An 8mm x 20cm interlock was selected for use.During the procedure, the coil could not advance in the middle part of the catheter.Subsequently, the physician tried pulling it backward for several times but the delivery shaft got twisted.The device was simply pulled out from the patient's body.The procedure was completed with another of same device.No patient complications were reported.However, device analysis revealed that the interlocking arm was detached.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14340780
• Report Number: 2134265-2022-05030
• Device Sequence Number: 6256782
• Product Code: KRD
• UDI-Device Identifier: 08714729765011
• UDI-Public: 08714729765011
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0028038862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 67 KG